University of Maryland, others work to improve drug manufacturing process

Barbara Haddock Taylor / Baltimore Sun

Barbara Haddock Taylor / Baltimore Sun

Meredith Cohn, The Baltimore Sun

At the University of Maryland School of Pharmacy, scientists are working on a database that will help drug makers decide which of 1,000 or so materials are safest and most effective to deliver specific medications.

It's a project that could get a big boost from a grant up to $35 million to a collection of universities from the U.S. Food and Drug Administration that aims to make the nation's drugs safer and less costly, and even produce more jobs, by improving the science of manufacturing. The money will be doled out over five years, depending on the availablilty of funds, and could also eventually help with prescription drug shortages that are leaving some cancer, surgery and other patients without needed medications.

The money doled out over five years could also eventually help with prescription drug shortages that are troubling the industry and leaving some cancer, surgery and other patients without needed medications.

"Almost all the [federal grant] money now goes to discovery of new drugs," said Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education, the nonprofit umbrella academic group that won the grant and will disperse the funds to 11 member universities. "We can discover any amount of new molecules, but if we can't take them to market as a safe product, those discoveries are meaningless."

The universities will attempt to address some of the problems with producing specific drugs as well as develop new ways to improve production overall, Basu said. With such investments, as well as others in training, outsourced research and manufacturing jobs could return to the United States, ensuring a ready domestic drug supply.

For the public, that could mean fewer drug recalls, fewer drugs that don't work as billed and a faster path to production of needed remedies. It takes about 10 years and $1 billion to bring a drug to market, Basu said.

All of the universities will publish and promote their findings so all manufacturers can benefit, said Natalie D. Eddington, professor and dean of Maryland's School of Pharmacy, which has about a half-dozen professors and fellows focused on such research. For now, individual drug makers use their own science to formulate and make drugs with FDA approval.

The data "will be out there for everyone to use," she said. "Manufacturers will say, 'Oh geez, this works so I'm going to use this approach and not waste dollars and time.' "

Maryland is hoping for a big slice of the grant money, the largest pledge to date to the coalition of universities from the FDA. Eddington said Maryland has expertise in "excipients," or nondrug materials used in tablets and capsules to bind or lubricate them, control or enhance a drug's release, aid their absorption or keep them from expiring.

A decision will be made in the next two months on project funding. At Maryland, the money could be used for research into excipients for skin patches and aerosol products, among others, as well as training for researchers and symposiums among academic, government and industry scientists.

Previous grants have funded the start of the excipient database project jointly developed at Maryland and Purdue University. Eventually it will contain information on up to 1,000 naturally or synthetically derived excipients.

Instead of each manufacturer having a recipe, scientists want to discover which work best with which drugs, cutting down on the guesswork, after-production failures and time spent by the FDA approving formulations.

After two years, the database includes about 50 excipients, said Stephen Hoag, an industrial pharmaceutics professor in Maryland's School of Pharmacy.

"There is no such thing as a super excipient," said Hoag, also director of the pharmacy school's Good Manufacturing Practices Core Facility. "We'd provide the tools to allow people to determine which is best in which case. We're finding excipients are not always interchangeable."

The information will be useful to industry scientists, who Hoag says have been meeting with the FDA and the university researchers to work on the issues.

Kate Connors, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, whose member companies spent $49.4 billion in 2010 in discovering and developing new medicines, said, "Efforts to improve our knowledge base are really important."